Latest news with #GoodManufacturingPractices
Time of India
14 hours ago
- Business
- Time of India
Gland Pharma shares in focus after subsidiary Cenexi gets 11 observations from French regulator
Gland Pharma shares will be in focus on Thursday after the company announced that its material subsidiary, Cenexi, received 11 observations from France's drug regulator, Agence nationale de sécurité du médicament et des produits de santé (ANSM), following a Good Manufacturing Practices (GMP) inspection at its Fontenay manufacturing facility. In a stock exchange filing, Gland Pharma stated: 'The ANSM, France, has issued its final report citing 11 observations pursuant to the GMP inspection of Cenexi's Fontenay manufacturing facility conducted between December 9 and December 19, 2024.' In response, Cenexi has submitted a Corrective and Preventive Action (CAPA) plan, outlining measures to be implemented over a 3- to 12-month period, depending on the nature of each observation. The plan has been accepted by ANSM. Also Read: MRF snatches India's highest-priced stock crown back from Elcid Investments Live Events The company clarified that the observations will not impact manufacturing operations at the Fontenay site. Gland Pharma added that Cenexi is committed to resolving the issues in coordination with the French regulator and will continue to update stock exchanges on further developments. Also Read: These 10 Nifty microcap stocks can rally 70-200% in the next 12 months Gland Pharma Share Price Target and Performance According to Trendlyne, the average target price for Gland Pharma is Rs 1,678, implying a potential upside of 3% from current levels. Of the 12 analysts tracking the stock, the consensus rating is 'Hold'. On Wednesday, Gland Pharma shares closed 1.88% higher at Rs 1,623.7 on the BSE, while the Sensex gained 0.32%. The stock has rallied 16% in the last one month but remains down 43% over the past three years. The company's market capitalisation stands at Rs 26,751 crore. Also Read: Ola Electric, Kalyan Jewellers among 10 firms where promoters pledge increased in Q4 ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)
Fashion Value Chain
2 days ago
- Business
- Fashion Value Chain
Pharmacy Council of India Gives Nod to Chandigarh University, Uttar Pradesh to Launch Courses at School of Pharmacy
Chandigarh University, Uttar Pradesh, continues to break new ground in AI-augmented multidisciplinary education with a major milestone-its School of Pharmacy has received formal approval from the Pharmacy Council of India (PCI) for its Bachelor of Pharmacy (B. Pharma) programme. This development marks a significant step in establishing Uttar Pradesh as a forward-looking destination for pharmacy education. Chandigarh University Uttar Pradesh Officials After Receiving the Approval Letter from Pharmacy Council of India for Kick Starting Programs in Pharmacy at CU UP Campus The School of Pharmacy at CU Uttar Pradesh has been conceptualized with a future-ready educational model aligned with industry demands and driven by cutting-edge technology. The curriculum is designed to balance theoretical foundations with hands-on training, ensuring that students graduate as competent and industry-ready healthcare professionals. The Pharmacy Council of India has granted formal approval to Chandigarh University, Lucknow Campus to begin offering 60 seats in the Pharmacy course from the academic session 2025. State-of-the-Art Infrastructure for Research-Driven Learning The School of Pharmacy offers an infrastructure tailored for advanced research. Students actively participate in projects related to pharmacokinetics, clinical pharmacy, medicinal chemistry, and toxicology. The curriculum has been crafted in collaboration with international industry experts and academicians, enabling students to grasp both traditional and emerging subjects with clarity while sharpening their skills in line with global standards. The availability of AI-powered tools and modern laboratories encourages experiential learning. Students also engage in internships, research assignments, and community-driven projects, making education at CU not only theoretical but deeply practical and immersive. A Booming Sector with Expanding Opportunities With the global pharmaceutical industry projected to grow at an estimated rate of 4.7% from 2024 to 2029-reaching a market size of approximately USD 1,454 billion-career prospects in pharmacy remain robust. Recognizing this trend, Chandigarh University has developed an ecosystem equipped with high-tech labs, experienced industry professionals, and collaborative learning environments to prepare a skilled and adaptable workforce. Industry-Collaborated Education for Future-Ready Professionals Students at the School of Pharmacy can pursue careers in diverse fields such as Clinical Research, Intellectual Property Management, Regulatory Affairs, Quality Control, and Medical Writing. The university also imparts regulatory training in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), ensuring graduates are prepared to work in highly regulated environments. Chandigarh University, Uttar Pradesh, stands as a model of integrated education where learning, technology, and industry interface seamlessly. Students not only receive rigorous academic instruction but also benefit from industry training, internships, and research exposure, preparing them for a balanced and successful career. The universitys AI-supported, modern campus in Unnao-backed by industry-aligned curriculum, advanced labs, and seasoned faculty-provides a solid academic foundation. Strategic partnerships with leading companies and government bodies further enhance student opportunities by offering essential skill training and diverse career pathways. Academic Leadership at the Helm The school is led by Prof. (Dr.) Amit Verma. Prof. Verma is accompanied by rich international, industry, and academic experience. Having more than 20 years of pharmaceutical education, research, and industrial experience, Prof. Verma has made notable contributions towards international collaborations, drug development plans, regulatory documentation, and innovation in pharmaceutical sciences. He has collaborated with Indias and the worlds premier institutions and pharmaceutical industries, providing his services in drug discovery, formulation science, regulatory affairs, clinical research and academic leadership. His passion for pharmacy education is evident in his strong desire for interactive learning, digital integration, research mentorship, and international academic collaborations. Being the Indias first AI-enabled campus Chandigarh University Uttar Pradesh is committed to revolutionize education through modern technology. This smart campus offers AI-powered learning platforms, real-time simulation, virtual labs, that foster an environment of incubation, innovation and critical thinking. The university believe in quality professional education where the eminent faculty on roll are equipped with advanced pedagogy to produce pharmacy professionals to not only adept in their field but also competent in leveraging technology to enhance patient care and drug development. This initiative and commitment ensure our dedication to shape future-ready pharmacy leaders to meet healthcare industry requirement. Backed with the legacy of Chandigarh University Mohali, students will get an opportunity for the international exposure through the collaborations with over 150 foreign universities, enriching their academic and cultural perspectives. Chandigarh University Uttar Pradesh is committed to nurturing competent and compassionate pharmacy professionals who can contribute meaningfully to the global healthcare ecosystem'. About Chandigarh University Uttar Pradesh (Lucknow) Envisioned to foster a culture of sustainability and empower future global leaders, Chandigarh University, Uttar Pradesh, immerses 21st-century learners in a personalised and experiential learning experience, integrating an AI-powered academic model and a multidimensional, futuristic perspective on education. Our Uttar Pradesh campus carries forward the venerable legacy of more than a decade of Chandigarh University, Punjab, which has established itself as Indias No. 1 Private University and a torchbearer of groundbreaking pedagogy and research-driven innovation. The AI-augmented new campus offers a broad spectrum of industry-driven futuristic academic programs encompassing data-driven insights, virtual reality experiences, real-world simulations, corporate mentorship, international perspective, interdisciplinary research, cultivation of entrepreneurial spirit, and professional competencies. Website:
Business Standard
4 days ago
- Business
- Business Standard
Cipla's Bengaluru facility gets one USFDA observation
Cipla announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Bommasandra, Bengaluru. According to a regulatory filing, the inspection was carried out from 26 May 2025 to 30 May 2025. At the conclusion of the inspection, the USFDA issued one observation in Form 483. The company stated that it will work closely with the USFDA and remains committed to addressing the observation comprehensively within the stipulated timeframe. In Q4 FY25, Cipla reported a 30.1% year-on-year increase in consolidated net profit to Rs 1,222 crore, while total income rose 9.2% to Rs 6,730 crore. Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets. The scrip shed 0.19% to currently trade at Rs 1,462 on the BSE.
Business Upturn
4 days ago
- Business
- Business Upturn
Piramal Pharma successfully clears US FDA GMP inspection at Aurora facility
By Aman Shukla Published on June 2, 2025, 10:32 IST Piramal Pharma Limited has successfully completed the US FDA Good Manufacturing Practices (GMP) inspection at its Aurora, Canada facility. The inspection took place from May 26 to May 30, 2025. The US FDA conducted a thorough general GMP inspection, evaluating the facility's compliance with stringent manufacturing standards. Piramal Pharma's Aurora site was awarded a clean slate with zero Form 483 observations and received a No Action Indicated (NAI) designation, underscoring its commitment to excellence and regulatory compliance. This successful inspection reinforces Piramal Pharma's position as a leading pharmaceutical company dedicated to maintaining the highest quality standards in drug manufacturing. The company continuously strives to ensure the safety, efficacy, and quality of its products for patients worldwide. This successful inspection reinforces Piramal Pharma's position as a leading pharmaceutical company dedicated to maintaining the highest quality standards in drug manufacturing. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
4 days ago
- Business
- Business Upturn
Alembic Pharma shares dip over 2% after USFDA issues 4 observations for Panelav facility
By Aman Shukla Published on June 2, 2025, 10:25 IST Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company's API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90. The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors. The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are 'addressable' and reiterated its commitment to maintaining high standards of quality and regulatory compliance. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
